Department of Medical Microbiology, UMC Utrecht, Utrecht, The Netherlands.
Laboratory of Clinical Microbiology and Infectious Disease, Isala, Zwolle, Overijssel, The Netherlands.
BMJ Open. 2021 Oct 13;11(10):e048206. doi: 10.1136/bmjopen-2020-048206.
Antigen-based point-of-care tests for identification of SARS-CoV-2 may markedly enhance effectiveness of population-based controlling strategies. Previous studies have demonstrated >70% sensitivity and high specificity compared with reverse transcriptase real-time PCR (RT-PCR) in symptomatic individuals, but test performance for asymptomatic individuals is unknown.
Test performance of the Panbio COVID-19 Ag Rapid Test (Abbott) was compared with RT-PCR in a longitudinal cohort study of asymptomatic football players and staff members of professional football clubs. Based on timing of symptoms and prior and subsequent test results, positive RT-PCR tests were categorised as presymptomatic, early or late infection, or persistent RNA shedding.
2425 tests were performed in 824 individuals, of which 52 (6.3%) were SARS-CoV-2 positive based on RT-PCR. There were 2406 paired sets from asymptomatic subjects for analysis. Sixteen Panbio tests were inconclusive, for which sensitivity analyses were performed (considering results as either positive or negative or being excluded). Sensitivity of Panbio for screening of asymptomatic individuals ranged from 80.0% (61.4-92.3) to 86.67% (69.2-96.2) and specificity from 99.53% (95% CI 99.2 to 99.8) to 100% (95% CI 99.8 to 100). Sensitivity of Panbio to detect subjects with presymptomatic/early infection (n=42) ranged from 81.82% (95% CI 67.3 to 91.8) to 90.91% (95% CI 78.3 to 97.5) with specificity always above 99%.
The Panbio COVID-19 Ag rapid test identifies 81%-90% of presymptomatic and early asymptomatic SARS-CoV-2 infections with high specificity. This test may therefore be adopted in testing strategies such as targeted screening of specific populations where prevalence is low.
基于抗原的即时检测（POC）可显著提高基于人群的防控策略的效果，用于识别 SARS-CoV-2。既往研究显示，与实时逆转录 PCR（RT-PCR）相比，在有症状个体中，该检测的敏感性＞70%，特异性高，但在无症状个体中的检测性能尚不清楚。
在一项对无症状职业足球运动员和工作人员的纵向队列研究中，我们比较了 Panbio COVID-19 Ag 快速检测（ Abbott）与 RT-PCR 的检测性能。根据症状出现的时间以及先前和后续的检测结果，将阳性 RT-PCR 检测结果分为无症状期、早期或晚期感染或持续 RNA 脱落。
在 824 名个体中进行了 2425 次检测，其中 52 例（6.3%）基于 RT-PCR 检测为 SARS-CoV-2 阳性。有 2406 对来自无症状受试者的配对检测结果用于分析。16 次 Panbio 检测结果不确定，进行了敏感性分析（将结果视为阳性或阴性或排除）。Panbio 用于筛查无症状个体的敏感性为 80.0%（61.4-92.3）至 86.67%（69.2-96.2），特异性为 99.53%（95%CI 99.2-99.8）至 100%（95%CI 99.8-100）。Panbio 检测有症状/早期感染（n=42）受试者的敏感性为 81.82%（95%CI 67.3-91.8）至 90.91%（95%CI 78.3-97.5），特异性均＞99%。
Panbio COVID-19 Ag 快速检测可发现 81%-90%的无症状和早期无症状 SARS-CoV-2 感染，具有高特异性。因此，该检测可用于低流行率特定人群的有针对性筛查等检测策略。
